Trial Outcomes & Findings for Laboratory Assessment of Pilairo Q CPAP Mask Performance and Ease of Use. (NCT NCT02121912)
NCT ID: NCT02121912
Last Updated: 2019-06-24
Results Overview
Sleep technicians reported on their experience using the mask after 1 night in the lab on a scale from 1 to 10 with a higher score indicating a better experience
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
1 night in the lab
Results posted on
2019-06-24
Participant Flow
Participant milestones
| Measure |
FPH Pilairo Q CPAP Mask
The Sleep Technician will fit the FPH Pilairo Q CPAP mask to the participant.
FPH Pilairo Q CPAP mask: CPAP nasal-pillow mask
|
Any Other Market Released Nasal or Nasal-pillow CPAP Mask
The Sleep Technologist will fit the participant with any market released nasal or nasal-pillow CPAP mask
Any other market released nasal or nasal-pillow CPAP mask: Any other market released nasal or nasal-pillow CPAP mask
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
21
|
25
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
FPH Pilairo Q CPAP Mask
n=25 Participants
The Sleep Technician will fit the FPH Pilairo Q CPAP mask to the participant.
FPH Pilairo Q CPAP mask: CPAP nasal-pillow mask
|
Any Other Market Released Nasal or Nasal-pillow CPAP Mask
n=25 Participants
The Sleep Technologist will fit the participant with any market released nasal or nasal-pillow CPAP mask
Any other market released nasal or nasal-pillow CPAP mask: Any other market released nasal or nasal-pillow CPAP mask
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age : 18 + years
|
25 participants
n=25 Participants
|
25 participants
n=25 Participants
|
50 participants
n=50 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=25 Participants
|
6 Participants
n=25 Participants
|
10 Participants
n=50 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=25 Participants
|
19 Participants
n=25 Participants
|
40 Participants
n=50 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Germany
|
25 Participants
n=25 Participants
|
25 Participants
n=25 Participants
|
50 Participants
n=50 Participants
|
PRIMARY outcome
Timeframe: 1 night in the labPopulation: While not all participants completed the full study, participants who provided acceptable data were used in the analysis. The number of participants analyzed may be different from the number who completed. Due to the nature of this study, participant completion did not have a direct effect on this outcome measure.
Sleep technicians reported on their experience using the mask after 1 night in the lab on a scale from 1 to 10 with a higher score indicating a better experience
Outcome measures
| Measure |
FPH Pilairo Q CPAP Mask
n=24 Participants
The Sleep Technician will fit the FPH Pilairo Q CPAP mask to the participant.
FPH Pilairo Q CPAP mask: CPAP nasal-pillow mask
|
Any Other Market Released Nasal or Nasal-pillow CPAP Mask
n=25 Participants
The Sleep Technologist will fit the participant with any market released nasal or nasal-pillow CPAP mask
Any other market released nasal or nasal-pillow CPAP mask: Any other market released nasal or nasal-pillow CPAP mask
|
|---|---|---|
|
Subjective Questionnaire of Mask Experience
|
8.08 units on a scale
Standard Deviation 2.39
|
8.12 units on a scale
Standard Deviation 2.37
|
SECONDARY outcome
Timeframe: Every 10min, for up to 8 hoursThe Sleep Technologist will record mask leak every 10minutes, over an 8 hour period during the sleep study.
Outcome measures
| Measure |
FPH Pilairo Q CPAP Mask
n=24 Participants
The Sleep Technician will fit the FPH Pilairo Q CPAP mask to the participant.
FPH Pilairo Q CPAP mask: CPAP nasal-pillow mask
|
Any Other Market Released Nasal or Nasal-pillow CPAP Mask
n=25 Participants
The Sleep Technologist will fit the participant with any market released nasal or nasal-pillow CPAP mask
Any other market released nasal or nasal-pillow CPAP mask: Any other market released nasal or nasal-pillow CPAP mask
|
|---|---|---|
|
Mask Leak
|
38.36 liters/minute
Standard Error .99
|
35.47 liters/minute
Standard Error 1.43
|
SECONDARY outcome
Timeframe: 1 night in the labSleep Technicians reported on whether they would recommend the mask to other professionals. Ratings were out of 1-10 and a higher score indicates a higher likelihood of recommending the mask.
Outcome measures
| Measure |
FPH Pilairo Q CPAP Mask
n=24 Participants
The Sleep Technician will fit the FPH Pilairo Q CPAP mask to the participant.
FPH Pilairo Q CPAP mask: CPAP nasal-pillow mask
|
Any Other Market Released Nasal or Nasal-pillow CPAP Mask
n=23 Participants
The Sleep Technologist will fit the participant with any market released nasal or nasal-pillow CPAP mask
Any other market released nasal or nasal-pillow CPAP mask: Any other market released nasal or nasal-pillow CPAP mask
|
|---|---|---|
|
Sleep Technicians Recommendation to Use Mask
|
8.83 units on a scale
Standard Deviation 1.47
|
8.17 units on a scale
Standard Deviation 1.85
|
Adverse Events
FPH Pilairo Q CPAP Mask
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Any Other Market Released Nasal or Nasal-pillow CPAP Mask
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
FPH Pilairo Q CPAP Mask
n=25 participants at risk
The Sleep Technician will fit the FPH Pilairo Q CPAP mask to the participant.
FPH Pilairo Q CPAP mask: CPAP nasal-pillow mask
|
Any Other Market Released Nasal or Nasal-pillow CPAP Mask
n=25 participants at risk
The Sleep Technologist will fit the participant with any market released nasal or nasal-pillow CPAP mask
Any other market released nasal or nasal-pillow CPAP mask: Any other market released nasal or nasal-pillow CPAP mask
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.0%
1/25 • Number of events 1 • 1 night 1 Night in Lab. Adverse event data was collected for the full time each participant remained in the trial, from informed consent until study completion or withdrawal. Each participant spent a different amount of time in the lab enrolled in the trial due to their sleep behavior. Therefore, a specific amount of time (or average) is not appropriate.
|
0.00%
0/25 • 1 night 1 Night in Lab. Adverse event data was collected for the full time each participant remained in the trial, from informed consent until study completion or withdrawal. Each participant spent a different amount of time in the lab enrolled in the trial due to their sleep behavior. Therefore, a specific amount of time (or average) is not appropriate.
|
|
Respiratory, thoracic and mediastinal disorders
Low SpO2
|
4.0%
1/25 • Number of events 1 • 1 night 1 Night in Lab. Adverse event data was collected for the full time each participant remained in the trial, from informed consent until study completion or withdrawal. Each participant spent a different amount of time in the lab enrolled in the trial due to their sleep behavior. Therefore, a specific amount of time (or average) is not appropriate.
|
0.00%
0/25 • 1 night 1 Night in Lab. Adverse event data was collected for the full time each participant remained in the trial, from informed consent until study completion or withdrawal. Each participant spent a different amount of time in the lab enrolled in the trial due to their sleep behavior. Therefore, a specific amount of time (or average) is not appropriate.
|
Additional Information
Clinical Research Scientist
Fisher and Paykel Healthcare
Phone: +64 09 574 0123
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place